PDC Biotech GmbH (PDC) has announced that it has successfully completed a phase I clinical trial for its lead compound for the treatment of preterm labour.
This study was designed to evaluate safety as well as provide proof-of-concept for the ability of the compound to inhibit excessive uterine contractility.
The study was conducted in healthy women with primary dysmenorrhea , a condition associated with painful, labour-like contractions which occur during menstruation.
PDC31 infusion was associated with a dose-dependent relief of pain, as well as a reduction in intrauterine pressure.
In addition, the drug was very well tolerated and there were no dose limiting toxicities.
The results from this study support the continued development of PDC31 for both preterm labour and primary dysmenorrhea.
Dr. Roman Götz, Managing Director of the company said: “We are pleased with the encouraging results of this study, which now enable us to move forward into further development for the preterm labour indication.”
Dr. Ernest Loumaye (Chairman of the Board) said: “The first administration in human study is an important step toward the development of this first in class compound, as the compound is well tolerated and pharmacodynamic results provide preliminary evidence in man of the validity of the target for the selected indications.”